Clinical Competency for MEDICAL DEVICES

Name Role:

Base: Date initial training completed:

Medical Device Document Relates To

( this document can also be completed as a training guide and template)

Competency Statement:
The participant must perform this activity without assistance and/or direct supervision (level
3) for level descriptors see end.
This document is a self-assessment for registered practitioners. Non registered staff should
be signed off by a registered practitioner competent to Level 4.
Line managers must have final sign off for all staff.

Level Assessor/self
Performance Criteria Assessment Method Date
achieved assessed

Verbal Questioning /
The Participant will be able to: Demonstration

1. Understand what the device is

to be used.

2. Has read and / or viewed any

manufacturers materials
relating to the medical device
3. Demonstrates an
understanding of the
specifications of the device
4. Shows understanding and
competency in setting up the
device correctly
5. Understands any safety features
on the device and the rationale
for them being there.
6. Understands the difference
between models and the effects
this may have on safety and
function of the device
7. How to set the controls on the
device appropriately
8. Recognise and malfunction or
error from the device and take
appropriate action
9. An awareness of the reliance
that should be placed on the
device to perform it’s required
task.
10) An understanding of how the
device produces results and the
reliance that should be placed
on these.
11) An understanding of the safety
features available on the device
and the level of reliance that
should be placed on them.

Medical Devices Clinical Competency (LEaD 7.0)

 Level Assessor/self
Performance Criteria Assessment Method Date
achieved assessed

12) Demonstrates safe practice by

ensuring they double check
both the patient and the device.
13) Demonstrates and
understanding of and
appropriately sets and uses any
alarms.
14) Able to discuss any potential
problems that may arise from the
device as well as any likely
/potential causes of failure
15) Able to monitor and check safe
functioning of the device as per
manufacturers guidance

16) Able to recognise when the

device has failed

17) Able to recognise any common

faults in the use of the device
18) Appropriately consults
manufacturer’s instructions or
seeks guidance when required
19) Is able to dissemble and
reassemble (including
accessories) for safe
decontamination of the device
20) Is able to decontaminate / clean
the device as appropriate

21) Demonstrates understanding of

optimal storage of the device

22) Able to report any concerns

relating to the use of the device

23) When and how to obtain

assistance or advice
Source SH CP 40 Medical Devices Policy (2014) SH CP 41 Medical Devices Toolkit (2014) Appendix B Toolkit

Date all elements of Competency Tool completed to level 3 ________

I confirm that I am competent to use this named piece of equipment

Name ______________Signature ______________Status___________ Date _______

I confirm that I have assessed the above named person and can verify that he/she
demonstrates competency in using the named medical device

Verifier / Manager ____________________________Signature _____________________

Status________________________________ Date _______________________

Review Competent Registered Verifier signature Comments

Dates: Yes / No Nurse Signature
Medical Devices Clinical Competency (LEaD 7.0)
 Levels of competency Rating Scale
Level of achievement Level
Novice Cannot perform this activity satisfactorily to the level required in 0
order to participate in the clinical environment
Can perform this activity but not without constant supervision 1
and assistance

Can perform this activity with a basic understanding of theory 2

and practice principles, but requires some supervision and
assistance
Competent Can perform this activity with understanding of theory and 3
Practitioner practice principles without assistance and/or direct supervision
Can perform this activity with understanding of theory and 4
practice principles without assistance and/or direct supervision,
at an appropriate pace and adhering to evidence based practice

At this level competence will have been maintained for at least 6

months and/or is used frequently (2-3 times /week) The
practitioner will demonstrate confidence and proficiency and
show fluency and dexterity in practice
This is the minimum level required to be able to assess
practitioners as competent

Can perform this activity with understanding of theory and 5

practice principles without assistance and/or direct supervision,
at an appropriate pace and adhering to evidence based practice.

At this level the practitioner will be able to adapt knowledge and

skill to special/ novel situations where there may be increased
levels of complexity and/or risk
Expert Can perform this activity with understanding of theory and 6
practice principles without assistance and/or direct supervision,
at an appropriate pace and adhering to evidence based practice.
Demonstrate initiative and adaptability to special problem
situations, and can lead others in performing this activity

At this level the practitioner is able to co-ordinate, lead and

assess others who are assessing competence. Ideally they will
have a teaching and /or mentor qualification

Adapted from: Herman GD, Kenyon RJ (1987) Competency-Based Vocational Education. A Case Study,
Shaftsbury, FEU, Blackmore Press, cited in Fearon, M. (1998) Assessment and measurement of competence in
practice, Nursing Standard 12(22), pp43-47

Medical Devices Clinical Competency (LEaD 7.0)